NCT05876117

Brief Summary

Claustrophobia is an irrational fear of restriction and suffocation. It is a specific phobia, according to DSM 5. Claustrophobic patients may fear that restriction of their limbs will hinder their ability to move quickly towards safety. MRI may trigger claustrophobia, because this diagnostic procedure involves a patient laying in a narrow tube. Premedication before MRI scan may occasionally reduce claustrophobia. Prospective observational crossover study of claustrophobic patients who are undergoing MRI scan. At alternate MRI scan sessions, each patient receives rotational premedication using Lorazepam 1mg; or Clonidine tablet 0.2mg; or combined Clonidine 0.2mg + Lorazepam 1mg. Patient will use Claustrophobia Questionnaire, a validated tool, to collect data on the days before and after each MRI scan. CLQ is a patient-administered tool used to assess claustrophobia. In addition, patient will use General Anxiety Disorder Questionnaire, a validated tool, to collect data on the days before and after each MRI scan. GAD-7 is a patient-administered tool that is used to assess anxiety.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 4, 2020

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

May 5, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

May 25, 2023

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

January 27, 2025

Status Verified

January 1, 2025

Enrollment Period

5.5 years

First QC Date

May 5, 2023

Last Update Submit

January 23, 2025

Conditions

Keywords

Claustrophobia MRI

Outcome Measures

Primary Outcomes (1)

  • Rate of completion of MRI scan

    Patient is calm and cooperative, completes MRI scan

    12 weeks

Study Arms (1)

Claustrophobic adult patients

Claustrophobic adult patients who are undergoing MRI scan as part of chronic pain management.

Eligibility Criteria

Age20 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult claustrophobic patients who are undergoing MRI scan as part of chronic pain management. Previous incomplete MRI because of claustrophobia.

You may qualify if:

  • diagnosed with claustrophobia
  • previous incomplete MRI because of claustrophobia
  • adult patients
  • good treatment compliance
  • reliable Claustrophobia Questionnaire (CLQ) diary
  • reliable General Anxiety Disorder Questionnaire (GAD) diary
  • informed consent for diary review
  • consent for clinical record quality assurance review

You may not qualify if:

  • poor treatment compliance
  • cognitive disorder
  • inability to provide consent
  • major neuropsychiatric disorder
  • unreliable diary
  • cannabis use
  • excessive alcohol intake
  • previous adverse/allergic reactions to clonidine
  • previous adverse/allergic reactions to lorazepam

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Salem Anaesthesia Pain Clinic

Surrey, British Columbia, V3S 7J1, Canada

RECRUITING

MeSH Terms

Conditions

Claustrophobia

Condition Hierarchy (Ancestors)

Phobic DisordersAnxiety DisordersMental Disorders

Study Officials

  • Olu Bamgbade, MD,FRCPC

    Salem Anaesthesia Pain Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Olu Bamgbade, MD,FRCPC

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2023

First Posted

May 25, 2023

Study Start

July 4, 2020

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

January 27, 2025

Record last verified: 2025-01

Locations